Medical device manufacturing and marketing in the U.S.A. is regulated by the FDA. Medical device manufacturers must register with the FDA and produce their products with a Quality System that meets the FDA Quality System Regulation and more precisely with the 21 CFR 820. Compliance with regulations is crucial and requires an investment of both […]
ISO 9001 versus ISO 13485 – What are the differences and which certification is best adapted to medical devices manufacturers?
Developing products with highest quality standards is essential for medical device manufacturers. Having been certified to both ISO 9001 and ISO 13485 for the past decade, Valtronic and quality manufacturing are long time companions. However, is […]
Successful transfer of PCB assemblies for The Telos Alliance® – The Grass is Greener at Valtronic
The decision to switch from one Contract Manufacturer (CM) to another is not made lightly as it takes extra effort on both the CM and customer’s part to ensure that production is not slowed. Companies switch CM’s for a variety […]
One would quickly describe the position of Document Control as the “police” of an organization that maintains tight jurisdiction and follows strict guidelines to controlling all aspects of internal documentation.
So let’s define what Document Control really does in an and contract manufacturing world.
- Collects, maintains and distributes all documents necessary to define product configuration and […]
As I am working on entering first pass yield data into a system I have created for Valtronic, I am reminded of past businesses that I have worked for. In those positions, the Quality system (or Quality Management System – QMS) was a key identification tool to help businesses and their customers thrive. The QMS systems […]